Primary Cutaneous AmyloidosisNCT07143864
Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis
A study testing Stapokibart in people with Primary Cutaneous Amyloidosis, run by First Affiliated Hospital of Chongqing Medical University.
Trial summary
This trial is planned to investigate the efficacy and safety of Stapokibart (an IL-4 receptor antagonist) in patients with PCA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Cutaneous Amyloidosis
- What is being tested?
- Stapokibart
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 to 75 years, with a diagnosis of PCA confirmed by skin biopsy, and an IGA score of ≥3, a AASI score of ≥5, and a BSA involvement of ≥5%.
- Subjects who have received at least 4 weeks of mid-to-high potency or at least 2 weeks of very high potency topical corticosteroids (TCS) or an adequate course of systemic corticosteroids within the 6 months prior to screening, but with an inadequate response; or subjects who are unable to receive the above treatments due to adverse reactions or potential risks.
- Prior to the first dose, subjects must have used a moisturizer continuously for at least 1 week, once daily, and must continue to use it throughout the study period.
- Able to understand and complete study-related questionnaires.
- Able to read, understand, and are willing to sign the informed consent form.
- Willing and able to comply with study visits and related procedures.
- Women of childbearing potential must agree to use contraception (such as intrauterine devices, oral contraceptives, or condoms) during the study and for 6 months after the study ends; must have a negative serum pregnancy test within 7 days before the first dose and must not be breastfeeding; male subjects must agree to use contraception during the study and for 6 months after the study ends.
Who cannot join
- Use of any of the following treatments within 4 weeks prior to randomization: a. Immunosuppressants or immunomodulators, such as systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon gamma (IFN-γ), azathioprine, methotrexate, and Janus kinase (JAK) inhibitors; b. UV phototherapy; c. Systemic traditional Chinese medicine (TCM) treatment.
- Use of topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), TCM, or phosphodiesterase 4 (PDE-4) inhibitors within 2 weeks prior to randomization.
- Receipt of anti-IL-4R monoclonal antibodies, anti-IgE monoclonal antibodies, or other biologics within 12 weeks or 5 half-lives (whichever is longer) prior to randomization.
- Receipt of live attenuated vaccines within 12 weeks prior to randomization or planned vaccination during the study period.
- Use of antihistamines within 1 week prior to randomization (subjects who have been on a stable dose of antihistamines for at least 7 days prior to randomization and plan to continue during the study period may be included).
- Receipt of allergen-specific immunotherapy (desensitization therapy) within 6 months prior to randomization.
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- Presence of any skin comorbidities that may interfere with study assessments, including but not limited to scabies, cutaneous T-cell lymphoma, psoriasis, etc.
- Previous receipt of at least 12 consecutive doses of anti-IL-4Rα or IL-13 monoclonal antibodies with inadequate clinical response (defined as failure to achieve AASI 50 during treatment).
- Presence of any other significant medical history that the investigator deems would pose a risk to the subject's safety or be poorly controlled if the subject participates in the study, in addition to PCA.
- History of known or suspected immunosuppression (immunodeficiency), including a history of invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis), even if the infection has resolved; or unusual frequency, recurrence, or chronicity of infections (at the investigator's discretion).
- Subjects with any type of active malignancy or a history of malignancy (except for cervical cancer that has been cured for more than 5 years prior to the screening period, or non-metastatic squamous cell carcinoma of the skin, basal cell carcinoma, and papillary thyroid cancer).
- Presence of active Mycobacterium tuberculosis infection.
- Subjects with severe liver or kidney function impairment during the screening period, such as aspartate aminotransferase or alanine aminotransferase >2 times the upper limit of normal (ULN), total bilirubin >1.5 times ULN, serum creatinine >1.2 times ULN, etc.
- Presence of active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and HBV-DNA, or positive for hepatitis C virus (HCV) antibody and HCV-RNA.
- Positive for HIV antibody during the screening period, or history of HIV infection.
- Positive for Treponema pallidum antibody during the screening period (subjects who have undergone standard treatment and have a negative non-treponemal antigen serological test may participate in the study).
- Participation in another clinical trial of a drug or medical device within 12 weeks prior to randomization.
- Presence of chronic active or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to randomization. After resolution of the infection, the subject may be re-screened once.
- Subjects who plan to undergo major surgical procedures during the study period.
- Pregnant or breastfeeding women.
- Subjects with a history of alcoholism, drug abuse, or known drug dependence.
- History of atopic keratoconjunctivitis involving the cornea.
- Any medical or psychiatric conditions that the investigator deems would pose a risk to the subject, interfere with participation in the study, or confound the interpretation of study results.
About this study
Official title: Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis: A Randomized, Double-blind, Placebo-controlled Study
This trial is planned to investigate the efficacy and safety of Stapokibart (an IL-4 receptor antagonist) in patients with PCA.
- Conditions
- Primary Cutaneous Amyloidosis
- Being tested
- Stapokibart, Placebo drug
- Keywords
- primary cutaneous amyloidosis, Stapokibart
- Medical subject headings
- Amyloidosis, Primary Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StapokibartBiological
A humanized monoclonal antibody that targets the interleukin (IL)-4 receptor subunit alpha
Placebo drugOther
Placebo drugs without Stapokibart
| Study group | Role | What they receive |
|---|---|---|
| Stapokibart | Experimental | Not described Receives: Biological: Stapokibart |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects achieving AASI-75 at Week 16 of treatment
AASI: Amyloidosis Area and Severity Index. The minimum and maximum values: 0-72. Higher scores mean more serious situations.
AASI-75: A 75% or greater improvement from baseline in the AASI. The minimum and maximum values: 0%-100%. Higher scores mean a better outcome.
Measured: At the end of treatment at 16 weeks
Secondary outcomes (9)
The percentage of subjects with a weekly average reduction of≥4 points in PP-NRS score at Week 16 of treatment compared to baseline
PP-NRS: Peak Pruritus Numerical Rating Scale. The minimum and maximum values: 0-10. Higher scores mean more serious situations.
Measured: At the end of treatment at 16 weeks
The percentage of subjects with an IGA score of 0 or 1 and a reduction of≥2 points compared to baseline.
IGA: Investigator Global Assessment. The minimum and maximum values: 0-4. Higher scores mean more serious situations.
Measured: At the end of treatment at 16 weeks
The percentage of subjects achieving AASI-50 compared to baseline.
AASI: Amyloidosis Area and Severity Index. The minimum and maximum values: 0-72. Higher scores mean more serious situations.
AASI-50: A 50% or greater improvement from baseline in the AASI. The minimum and maximum values: 0%-100%. Higher scores mean a better outcome.
Measured: At the end of treatment at 16 weeks
The percentage of subjects with a weekly average reduction of≥3 points in PP-NRS score compared to baseline
PP-NRS: Peak Pruritus Numerical Rating Scale. The minimum and maximum values: 0-10. Higher scores mean more serious situations.
Measured: At the end of treatment at 16 weeks
Change rates in BSA involvement compared to baseline.
BSA: Body Surface Area. The minimum and maximum values: 0-100%. Higher scores mean more serious situations.
Measured: At the end of treatment at 16 weeks
Changes in DLQI scores compared to baseline.
DLQI: Dermatology Life Quality Index. The minimum and maximum values: 0-30. Higher scores mean more serious situations.
Measured: At the end of treatment at 16 weeks
Changes in absolute eosinophil counts in complete blood counts compared to baseline.
Measured: At the end of treatment at 16 weeks
Changes in IgE levels in complete blood counts compared to baseline.
Measured: At the end of treatment at 16 weeks
Changes in histopathology of skin lesions compared to baseline in some subjects
Measured: At the end of follow-up at 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Cutaneous AmyloidosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aijun Chen, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143864
- Sponsor's protocol ID
- CQMU-2025-215
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis: A Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07143864
- Acronym / sponsor ID
- CQMU-2025-215
- Conditions
- Primary Cutaneous Amyloidosis
- Keywords
- primary cutaneous amyloidosis, Stapokibart
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is planned to investigate the efficacy and safety of Stapokibart (an IL-4 receptor antagonist) in patients with PCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stapokibart | Experimental | Biological: Stapokibart |
| Placebo | Placebo comparator | Other: Placebo drug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females aged 18 to 75 years, with a diagnosis of PCA confirmed by skin biopsy, and an IGA score of ≥3, a AASI score of ≥5, and a BSA involvement of ≥5%.
- Subjects who have received at least 4 weeks of mid-to-high potency or at least 2 weeks of very high potency topical corticosteroids (TCS) or an adequate course of systemic corticosteroids within the 6 months prior to screening, but with an inadequate response; or subjects who are unable to receive the above treatments due to adverse reactions or potential risks.
- Prior to the first dose, subjects must have used a moisturizer continuously for at least 1 week, once daily, and must continue to use it throughout the study period.
- Able to understand and complete study-related questionnaires.
- Able to read, understand, and are willing to sign the informed consent form.
Key exclusion criteria (23 listed)
- Use of any of the following treatments within 4 weeks prior to randomization: a. Immunosuppressants or immunomodulators, such as systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon gamma (IFN-γ), azathioprine, methotrexate, and Janus kinase (JAK) inhibitors; b. UV phototherapy; c. Systemic traditional Chinese medicine (TCM) treatment.
- Use of topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), TCM, or phosphodiesterase 4 (PDE-4) inhibitors within 2 weeks prior to randomization.
- Receipt of anti-IL-4R monoclonal antibodies, anti-IgE monoclonal antibodies, or other biologics within 12 weeks or 5 half-lives (whichever is longer) prior to randomization.
- Receipt of live attenuated vaccines within 12 weeks prior to randomization or planned vaccination during the study period.
- Use of antihistamines within 1 week prior to randomization (subjects who have been on a stable dose of antihistamines for at least 7 days prior to randomization and plan to continue during the study period may be included).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StapokibartA humanized monoclonal antibody that targets the interleukin (IL)-4 receptor subunit alpha | Biological | Stapokibart |
| Placebo drugPlacebo drugs without Stapokibart | Other | Placebo |
Primary outcome
The percentage of subjects achieving AASI-75 at Week 16 of treatment
Time frame: At the end of treatment at 16 weeks
AASI: Amyloidosis Area and Severity Index. The minimum and maximum values: 0-72. Higher scores mean more serious situations. AASI-75: A 75% or greater improvement from baseline in the AASI. The minimum and maximum values: 0%-100%. Higher scores mean a better outcome.
9 secondary outcomes
The percentage of subjects with a weekly average reduction of≥4 points in PP-NRS score at Week 16 of treatment compared to baseline
Time frame: At the end of treatment at 16 weeks
The percentage of subjects with an IGA score of 0 or 1 and a reduction of≥2 points compared to baseline.
Time frame: At the end of treatment at 16 weeks
The percentage of subjects achieving AASI-50 compared to baseline.
Time frame: At the end of treatment at 16 weeks
The percentage of subjects with a weekly average reduction of≥3 points in PP-NRS score compared to baseline
Time frame: At the end of treatment at 16 weeks
Change rates in BSA involvement compared to baseline.
Time frame: At the end of treatment at 16 weeks
Changes in DLQI scores compared to baseline.
Time frame: At the end of treatment at 16 weeks
Changes in absolute eosinophil counts in complete blood counts compared to baseline.
Time frame: At the end of treatment at 16 weeks
Changes in IgE levels in complete blood counts compared to baseline.
Time frame: At the end of treatment at 16 weeks
Changes in histopathology of skin lesions compared to baseline in some subjects
Time frame: At the end of follow-up at 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stapokibart in people with Primary Cutaneous Amyloidosis, run by First Affiliated Hospital of Chongqing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects achieving AASI-75 at Week 16 of treatment (time frame: At the end of treatment at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.